NDC 76451-018

Sodium Fluoride F 18

Sodium Fluoride F-18

Sodium Fluoride F 18 is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by 3d Imaging Drug Design And Development Llc. The primary component is Sodium Fluoride F-18.

Product ID76451-018_6ecdc45b-6918-4bb1-a1d2-f1b6fad8df87
NDC76451-018
Product TypeHuman Prescription Drug
Proprietary NameSodium Fluoride F 18
Generic NameSodium Fluoride F-18
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA203777
Labeler Name3D Imaging Drug Design and Development LLC
Substance NameSODIUM FLUORIDE F-18
Active Ingredient Strength200 mCi/mL
Pharm ClassesRadioactive Diagnostic Agent [EPC],Radiopharmaceutical Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 76451-018-10

10 mL in 1 VIAL, GLASS (76451-018-10)
Marketing Start Date2018-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76451-018-11 [76451001811]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

NDC 76451-018-51 [76451001851]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

NDC 76451-018-10 [76451001810]

Sodium Fluoride F 18 INJECTION
Marketing CategoryANDA
Application NumberANDA203777
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-17

Drug Details

Active Ingredients

IngredientStrength
SODIUM FLUORIDE F-18200 mCi/mL

OpenFDA Data

SPL SET ID:eeaf4f42-e3c6-4e0a-aa79-89722511eaea
Manufacturer
UNII

Pharmacological Class

  • Radioactive Diagnostic Agent [EPC]
  • Radiopharmaceutical Activity [MoA]
  • Radioactive Diagnostic Agent [EPC]
  • Radiopharmaceutical Activity [MoA]

NDC Crossover Matching brand name "Sodium Fluoride F 18" or generic name "Sodium Fluoride F-18"

NDCBrand NameGeneric Name
13108-211Sodium Fluoride F 18Sodium Fluoride F 18
24445-623Sodium Fluoride F 18SODIUM FLUORIDE F 18
24562-002Sodium Fluoride F 18SODIUM FLUORIDE F-18
40028-512Sodium Fluoride F 18Sodium Fluoride F 18
49609-102Sodium Fluoride F 18SODIUM FLUORIDE F-18
52670-550Sodium Fluoride F 18sodium fluoride F 18
60055-623Sodium Fluoride F 18Sodium Fluoride F 18
67939-020Sodium Fluoride F 18Sodium Fluoride F 18
69126-002Sodium Fluoride F 18Sodium Fluoride F 18
73410-002Sodium Fluoride F 18Sodium Fluoride F 18
76451-018Sodium Fluoride F 18Sodium Fluoride F 18
76419-211Sodium Fluoride F 18Sodium Fluoride F 18
13267-542Sodium FluorideSodium Fluoride F 18
16129-002Sodium FluorideSODIUM FLUORIDE F 18
24275-0285Sodium FluorideSodium Fluoride F-18
47584-002Sodium FluorideSODIUM FLUORIDE F-18
49609-002Sodium FluorideSODIUM FLUORIDE F-18
51760-002Sodium FluorideSODIUM FLUORIDE F-18
52768-125Sodium FluorideSODIUM FLUORIDE F-18
62072-500Sodium FluorideSODIUM FLUORIDE F-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.